All
CMOs Unveil Expansion and Investment Plans at InformexUSA
February 22nd 2007InformexUSA, San Francisco (Feb. 14?16)-Several contract manufacturing organizations (CMOs) and technology providers used InformexUSA to announce plans to expand manufacturing capabilities, increase service offerings, and ramp up other investments.
WHO Stresses Lack of Capacity for Pandemic Flu Vaccine
February 22nd 2007Geneva, Switzerland (Feb. 16)-During a two-day meeting, the World Health Organzation announced ?encouraging progress? in the development of a pandemic influenza vaccine but admitted that the industry still ?lacks the manufacturing capacity to meet potential pandemic influenza vaccine demand.?
Expansion Plans, Technology Advancements, and Green Chemistry Highlighted at InformexUSA.
February 15th 2007InformexUSA, San Francisco (Feb. 12?Feb. 14)-Custom manufacturers of active pharmaceutical ingredients and intermediates are gathered at InformexUSA this week, with companies announcing investment plans and unveiling new technology
Congressional Bill Establishes Biogenerics Approval Path
February 15th 2007Washington, DC (Feb. 14)?A congressional team has reintroduced the ?Access to Life-Saving Medicine Act,? which establishes a process through which the US Food and Drug Administration can approve generic copies of biologic drugs.
SOCMA Comments on DHS's Proposal for Chemical Site Security
February 8th 2007Washington, DC (Feb. 7)-The Synthetic Organic Chemical Manufacturers Association (SOCMA) submitted comments to the US Department of Homeland Security in response to proposed DHS regulations on chemical site security, asking DHS to take into consideration the unique nature of the specialty batch manufacturing sector.
User Fees Bolster $2B FDA Budget
February 8th 2007Rockville, MD (Jan. 30)-The White House proposes a record $2 billion budget for FDA for the year that starts Sept. 30, 2007, an amount that consists of $1.6 billion in appropriated funds, plus some $450 million user fees for drugs, biologics, medical devices and other products.
FDA Proposes Additional Information to Better Track Biological Product Deviations
February 1st 2007Rockville, MD (Jan. 30)-The Food and Drug Administration?s Center for Biologics Evaluation and Research (CBER) is proposing an addendum to its current biologics reporting form to better classify potential recalls.
AstraZeneca Plans Production Rationalization and Job Cuts
February 1st 2007London (Feb. 1)-AstraZeneca PLC unveiled a plan to improve asset utilization within its global supply chain that involves rationalizing production assets and cutting staff. The company made the announcement as part of its fourth quarter and full-year 2007 financial results.
Cardinal Health Agrees to Sell Contract Services Unit to The Blackstone Group for $3.3 Billion
January 26th 2007Cardinal Health (www.cardinal.com) agreed to sell its contract services unit, Pharmaceutical Technologies and Services (PTS), to The Blackstone Group (New York, NY, www.blackstone.com) for roughly $3.3 billion in cash.
HHS Awards $132.5 Million toward H5N1 Vaccine Development
January 25th 2007The US Department of Health and Human Services (HHS, Washington, DC) has awarded three vaccine makers a total of $132.5 million to advance their strategies for adjuvant-containing vaccines to combat the H5N1 strain of avian influenza. Under the contracts, each company will build capacity to produce either 150 million does of the vaccine or enough adjuvant for 150 million doses within six months after the onset of an influenza pandemic.